SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE— 510(k) K925615

Name: FDA 510(k) clearance K925615
Creator: U.S. Food and Drug Administration
Published: 1993-03-26

Substantially Equivalent

Sorin Biomedica, Fiat, USA, Inc.

FDA 510(k) clearance K925615 for SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE, Substantially Equivalent on 1993-03-26. Applicant: Sorin Biomedica, Fiat, USA, Inc.. Device class: 2.

Clearance details

Applicant: Sorin Biomedica, Fiat, USA, Inc.
Product code: Code CBI
Device class: Class 2
Regulation: 21 CFR 868.5740
Advisory panel: Anesthesiology
Date received: 1992-11-06
Decision date: 1993-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.